Featured in this edition of iSpeak Reading Roundup, are the top blog posts from March 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

You have been an ISPE Member for 30 years! During that time, you have done so much for the Society (thank you!). Currently, you are the Co-Chair of ISPE Women in Pharma® and serve as a Board Member for the ISPE International Board of Directors and the ISPE Foundation Board. You have also worked with and Chaired numerous committees in the past. Can you share some of...

As the third (already!) month of 2021 is rapidly coming to its close, it is time for a recap and a look ahead. In the spirit of March being Women’s History Month, we’re taking this opportunity to focus on the women in our organization. Here’s a reflection on and celebration of some exciting past and future accomplishments for 2021, with women in the driver seat.

While I consider myself a long-time entrepreneur, the journey to begin my own consulting business started in Seattle over dinner with two colleagues. We were talking about what we want to do in our individual lives and sharing ideas about what those lives might look like. We discussed how our dreams could fit into what we each want to share with the world and the way the world is moving – so...

The past, present, and future were featured in the Opening Plenary Session at the 2021 ISPE Aseptic Conference. A record number of attendees at the virtual conference hear remembrances of the 30 years of the...

What Does Contract Manufacturing Look Like In Pharma?

Many factory productions can be outsourced to contract manufacturers (CMs) in order for businesses to continue providing quality products to their customers in a cost-effective way, and so they can focus on other aspects of their business, increasing their overall productivity and efficiency, and improving their bottom...

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from February 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are the most read online articles during February 2021. Learn more about cleaning classifications, steam sterilization, biopharma process validation and more for what visitors to the Pharmaceutical Engineering® Online site were reading last month.

The current COVID-19 pandemic has heightened the awareness and attention to virus safety and risk mitigation for manufacturers. Each manufacturer has a strategy in place to mitigate the risk, however by manufacturers working together, this can lead to synergies and best practices in the way that the risk is managed. Also, additional guidance is required by the Industry in a field that is...

On February 8, 2021, the ISPE Emerging Leaders Committee launched ISPE’s first virtual International Hackathon. 51 ISPE Student and Recent Graduates participated in the event; they were split into six teams and 14 ISPE Emerging Leaders and Industry Professionals served as dedicated coaches to the teams.

On February 8, 2021, the ISPE Emerging Leaders Committee launched ISPE’s first virtual International Hackathon. 51 ISPE Student and Recent Graduates participated in the event; they were split into six teams and 14 ISPE Emerging Leaders and Industry Professionals served as dedicated coaches to the teams.

On February 8, 2021, the ISPE Emerging Leaders Committee launched ISPE’s first virtual International Hackathon. 51 ISPE Student and Recent Graduates participated in the event; they were split into six teams and 14 ISPE Emerging Leaders and Industry Professionals served as dedicated coaches to the teams.

You’ve only been an ISPE Member for two years, but you’ve done so much in that time, including being named the International Women in Pharma Mentor Circle Leader. Can you tell us a little about how that came about and the successes the WIP Mentor Circle Program has experienced?

A technical working group under ISPE’s PQLI® Committee that is seeking to assist industry and regulators with implementation of ICH Q12 recently produced a webinar on

Aseptic filling of parenterals is one of the most challenging tasks within pharmaceutical manufacturing. There is a wide range of topics that fall under this umbrella, from more engineer-driven topics like filling accuracy and machine performance to key production questions, like how to keep the process sterile and compliant within the law and regulatory guidelines. All this is influenced by...

For as long as I can remember, I have always felt I was different. However, I have never felt it more than when I was in foreign countries, interacting with people from all over the world. These were some of my most life-changing experiences, and I have ISPE to thank for that, with it being such a diverse and inclusive community. I must admit that there were moments where I was uncomfortable –...

At the ISPE Singapore Affiliate’s 20th Anniversary Conference on 9-12 December 2020, two international regulators and a senior representative from industry discussed current and future collaboration between industry and regulatory authorities.

During 2020, the pressure points of the COVID-19 pandemic challenged us to broaden our thinking and change our practices. Adjustments were made at a global scale and more people were immersed in the experience of dealing with a crisis than ever before. This generated a spotlight on pharmaceutical supply chain practices. Patients and regulators were increasingly asking: what are best practices...